Impact Analyses: KVK-TECH received an OAI classification for its NEWTOWN facility.
KVK-TECH, INC. has received an ‘Official Action
Indicated (OAI)’ classification from the USFDA for its facility located at 110
Terry Drive, Newtown, Pennsylvania 18940, USA following an inspection
completed on April 13, 2025.
This Newtown facility is KVK’s manufacturing site for
US generics and is involved in the production of oral solids and liquids,
with a focus on controlled substances products.
- Majority
of KVK’s portfolio consists of controlled substances, which heightens
regulatory scrutiny.
- Almost all the products are solely
dependent on the Newtown facility, with no backup sites listed.
- Top 3 products in its portfolio
manufactured in this facility are contract manufactured for other
companies.
- 26 of the 38 products
manufactured at this facility are contract manufactured products.
- One product manufactured
at this facility owned by KVK Tech having notable 21.19% share in
its therapeutic category.
